Inflammation Clinical Trial
Official title:
Autophagy, Mitophagy, Inflammation and Plasmatic Concentration of Melatonin in Newborn With Metabolic Acidosis at Birth
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal
encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births. Over the last six years,
several randomized control trials have demonstrated that therapeutic hypothermia reduces the
rate of death or disability at 18 months of age among infants who survived. However, the
neurodevelopmental outcome in milder NE not treated with hypothermia remains unclear.
A multicenter prospective observational study will be conducted to determine biological
changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .
It is a prospective observational multicenter study on 50 newborns with mild neonatal
encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia
compared to healthy controls.
Infants with metabolic acidosis at birth and evidence of mild encephalopathy graded according
to Sarnat&Sarnat neurological evaluation will be recruited to evaluate plasma concentration
of melatonin and levels of Autophagy, mitophagy and inflammation.
Plasmatic changes will be compared to:
- healthy control
- infants with isolated metabolic acidosis at birth and normal neurological evaluation.
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